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ERYTHROMYCIN ETHYLSUCCINATE GRANULES FOR ORAL SUSPENSION 500MG/5ML

Active substance(s): ERYTHROMYCIN ETHYL SUCCINATE

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Erythromycin Ethylsuccinate Granules for Oral Suspension
125mg/5ml, 250mg/5ml, 500mg/5ml
(erythromycin ethylsuccinate)









Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even of their symptoms are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. see section 4.

What is in this leaflet
1. What Erythromycin ethylsuccinate granules for oral suspension is and what it is used for.
2. What you need to know before you take Erythromycin ethylsuccinate granules for oral
suspension
3. How to take Erythromycin ethylsuccinate granules for oral suspension
4. Possible side effects
5. How to store Erythromycin ethylsuccinate granules for oral suspension
6. Contents of the pack and other information
1. WHAT ERYTHROMYCIN ETHYLSUCCINATE GRANULES FOR ORAL SUSPENSION IS
AND WHAT IT IS USED FOR.
Erythromycin is an antibiotic for the treatment and prevention of infections caused by
erythromycin sensitive organisms, such as:
• upper and lower respiratory tract infections
• eye, ear infections
• mouth/dental infections
• skin and soft tissue infections
• gastrointestinal infections
• sexually transmitted infections.
• Prophylaxis: pre- and post- operaive trauma, burns, rheumatic fever
• Other infections: osteomyelitis, urethritis, gonorrhoea, syphilis, lymphogranuloma
venereum, diphtheria, prostatitis and scarlet fever.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERYTHROMYCIN ETHYLSUCCINATE
GRANULES FOR ORAL SUSPENSION
Do not take Erythromycin ethylsuccinate granules for oral suspension if you are:
• allergic (hypersensitive) to erythromycin or any of the other ingredients in the product (listed
in Section 6 and end of Section 2)
• taking simvastatin, tolterodine, mizolastine, amisulpride, astemizole, terfenadine, domperidone,
cisapride or pimpozide, ergotamine and dihydroergotamine
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Erythromycin ethylsuccinate granules for

Erythromycin Ethylsuccinate
Granules for Oral Suspension
125mg/5mg, 250mg/5ml/500mg/5ml

Barcode

Erythromycin Ethylsuccinate
Granules for Oral Suspension
125mg/5mg, 250mg/5ml/500mg/5ml

PACKAGE LEAFLET: INFORMATION FOR THE USER

Barcode

Pharmacode position may change as per Supplier’s m/c requirement &
additional small pharma code may appear on the front / back panel

oral suspension if you:
• have kidney or liver problems
• are pregnant or trying to become pregnant
• are breast-feeding
• have previously experienced diarrhoea following the use of antibiotics
• are giving this medicine to young child and they vomit or become irritable when fed. If this
occurs contact your doctors immediately.
• suffer from myasthenia gravis.
Other medicines and Erythromycin ethylsuccinate granules for oral suspension
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other
medicines.
• warfarin (thins the blood)
• cisapride (used for stomach disorders)
• pimozide (used in the treatment of psychiatric disorders)
• clarithromycin (antibiotic used to treat certain infections)
• ergotamine or dihydroergotamine ( for migraine)
• theophylline (helps breathing)
• cilostazol (for blood circulation problems)
• rifabutin (for tuberculosis)
• sildenafil (for erectile dysfunction)
• vinblastine (for cancer)
• antifungals e.g. fluconazole, ketoconazole and itraconazole
• colchicine (for gout)
• Other drug interactions include: bromocriptine (used to treat Parkinson’s disease), digoxin or
disopyramide or quinidine (all heart drugs), hexobarbitone, midazolam (used as a sedative),
cyclosporin or tacrolimus (used following organ transplants), alfentanil, zopiclone or triazolam
(induces sleep)
Phenytoin or carbamazipine, valproate (drugs for epilepsy), lovastatin (a cholesterol lowering
agent), your doctor should monitor you appropriately and may adjust your dosage of erythromycin
as necessary.
Do not take simvastatin, tolterodine, mizolatine, amisulpride, terfenadine, domperidone or
astemizole (for the treatment of hayfever and other allergies) if you have been prescribed Erythromycin
ethylsuccinate granules for oral suspension.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or planning to become pregnant. Erythromycin passes into
breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant and treated with an oral erythromycin tablets for early syphilis. Please consult
your doctor as erythromycin mat not be effective in preventing infection to the baby.
Driving and using machines
Erythromycin ethylsuccinate granules for oral suspension is not expected to afect your ability to
drive or operate machinery.
Erythromycin ethylsuccinate granules for oral suspension contains sucrose

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This medicine contains sucrose which may br harmful to your teeth. If you know you have an
intolerance to some sugars, contact your doctor before taking the suspension.
3. HOW TO TAKE
SUSPENSION

ERYTHROMYCIN

ETHYLSUCCINATE

GRANULES

FOR

ORAL

Always take Erythromycin ethylsuccinate granules for oral suspension exactly as your doctor has
told you. The pharmacist’s label should tell you how much to take and how often.
For oral use only.
Adults, elderly &
children (over 8 years)
Children between 2 and
8 years
Infants and babies under
2 years

125mg/ 5ml
4 x 5ml teaspoonfuls,
4 times a day.
2 x 5ml teaspoonfuls,
4 times a day.
2 x 5ml teaspoonfuls,
twice a day.

250mg/5ml
500mg/5ml
2 x 5ml teaspoonfuls, 1 x 5ml teaspoonfuls,
4 times a day.
4 times a day.
1 x 5ml teaspoonfuls,
4 times a day.
1 x 5ml teaspoonfuls,
twice a day.

Children 2 - 8 years and < 2 years: 30mg/kg/day in divided doses. For severe infections up to
50mg/kg/day in divided doses.
It is important that you complete your full course of antibiotic, do not stop taking the suspension
early if you feel better.
If you take more Erythromycin ethylsuccinate granules for oral suspension than you should
If you or a child accidentally takes too much medicine, contact your doctor or nearest hospital emergency department immediately. Take this leaflet, the box and any suspension remaining with you,
if possible. Symptoms of overdose include nausea, vomiting and diarrhoea.
If you forget to take Erythromycin ethylsuccinate granules for oral suspension
If you miss a dose, take the suspension as soon as remember and carry on as before.
If it is almost time for your next dose, skip the missed dose and continue as usual (do not take a
double dose to make up for the forgotten dose).
If you have any further questions on the use of this product, ask your doctor o pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all other medicine, Erythromycin ethylsuccinate granules for oral suspension can cause side
effects, although not everyone gets them.
STOP taking this medicine and seek medical help IMMEDIATELY if you experience any of the
following reactions:
• a allergic reaction causing difficulty in breathing and swelling of certain parts of your body,
including the face and neck.
Other side effects which may occur are:
• increase number of eosinophils (white blood cells)
• irregular heart beats, palpitations and ventricular tachyarrhythmias
• hearing loss (usually taking high doses)
• upper abdominal discomfort, nausea, vomiting, diarrhoea, pancreatitis, anorexia, infantile
hypertrophic pyloric stenosis
• general symptoms such as chest pain, fever, malaise
• cholestatic hepatitis, jaundice, hepatic disfunction, hepatic failure







allergic reactions such as urticaria and mild skin eruption
confusion, seizures and vertigo
hallucinations (seeing or hearing things that are not real)
interstitial nephritis
hypotension (low blood pressure)

Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE ERYTHROMYCIN ETHYLSUCCINATE GRANULES FOR ORAL
SUSPENSION
Keep this medicine out of the sight and reach of children.
Unopened bottle: Do not store above 25°C. Store in the original container and keep tightly closed.
Do not use suspension after the expiry date is stated on the label.
Reconstituted suspension: Store 2- 8°C and use within 14 days.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to protect
the environment.
6. Contents of the pack and other information
What Erythromycin ethylsuccinate granules for oral suspension contains
The active substance is erythromycin ethylsuccinate.
The other ingredients are croscarmellose sodium, sodium citrate, banana flavour (E4210 SD),
quinoline yellow (E104), sodium saccharin, colloidal anhydrous silica, sucrose (see Section 2 ‘Important information about some of the ingredients of Erythromycin ethylsuccinate granules for oral
suspension’).
What Erythromycin ethylsuccinate granules for oral suspension looks like and contents of
the pack
The granules for oral suspension is a free flowing, yellow coloured granules, with a characteristic
banana odour which on reconstitution forms a thick, smooth suspension. The product is available
in three strengths (125mg/5ml, 250mg/5ml and 500mg/5ml), supplied in 100ml brown bottles with
a plastic screw-on cap.
Marketing Authorisation Holder and Manufacturer
Milpharm Limited,
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD,
United Kingdom

This leaflet was last approved in {10/2015}

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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